US 8,303,527 B2 · Orthopedic system for immobilizing and supporting body parts

Abstract

A unitized cast system for immobilizing and supporting a body part. The unitized casting system includes a first inner layer for padding and dissipating heat against the patient's skin. A second layer is formed from a thermoformable structural material such as perforated plastic. A protective third outer layer is provided to provide insulation for the second layer. These three layers are formed together to form a unitized cast system that is easily formed and applied to the patient.

Drawings

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Drawings

Claims21

Dependent claims

A cast system for supporting a body part, said cast system comprising:

a protective shell configured to be generally positioned at least partially circumferentially around the body part and moldable during a patient forming process at a target temperature range between 160 and 220 degrees Fahrenheit that is maintained by said shell during said patient forming process for a target dwell time of between 3 and 10 minutes, said shell having:
an inner layer defining an area generally facing toward the body part;
an outer layer defining an area generally facing away from the body part, said area of said outer layer being generally similar to said area of said inner layer;
and
a middle layer generally coextensive with said areas of said inner layer and said outer layer and completely encapsulated and sandwiched between said inner layer and said outer layer,
wherein said inner layer and said outer layer each comprise a foam layer and said middle layer comprises a polymer layer that is thermoformable within said target temperature range and generally rigid at temperatures below said target temperature range, and
wherein said foam layers have a lower density than said polymer layer of said middle layer and said foam layers and said middle layer are integrally formed as a composite layer material,
such that said foam layers stretch to conform to a moldable shape of said middle layer during said patient forming process and said foam layers insulate said middle layer to maintain said middle layer at said target temperature range during said target dwell time when said shell is heated to an initial temperature before said patient forming process of not more than 300 degrees Fahrenheit.

5 more elements

A cast system for a body part, said cast system comprising:

a shell means for positioning at least partially circumferentially around and for molding to the body part during a patient forming process having a target dwell time of between 3 and 10 minutes and a target temperature range of between 160 and 220 degrees Fahrenheit, said shell means including:
an inner layer defining an area generally facing toward the body part;
an outer layer defining an area generally facing away from the body part, said area of said outer layer being generally similar to said area of said inner layer;
and
a middle layer generally coextensive with said areas of said inner layer and said outer layer and completely encapsulated and sandwiched between said inner layer and said outer layer and integrally formed with said inner layer and outer layer as a composite layer material,
wherein said middle layer comprises polymer means for thermoforming within said target temperature range during said patient forming process and for assuming a generally rigid moldable shape at temperatures below said target temperature range after said patient forming process;
and
wherein said inner layer and said outer layer each comprise foam means for stretching to conform to said moldable shape within said target temperature range during said patient forming process and for insulating said middle layer to maintain said middle layer at said target temperature range during said target dwell time when said shell means is heated to an initial temperature before said patient forming process of not more than 300 degrees Fahrenheit.

5 more elements

A method for applying a cast to a body part of a patient, said cast including an protective shell having an inner layer defining an area generally facing toward the body part, an outer layer defining an area generally facing away from the body part, said area of said outer layer being generally similar to said area of said inner layer, and a middle layer generally coextensive with said areas of said inner layer and said outer layer and completely encapsulated and sandwiched between said inner layer and said outer layer, wherein said inner layer and said outer layer each comprise a foam layer that is stretchable within a target temperature range of between 160 and 250 degrees Fahrenheit and said middle layer comprises a polymer layer that is thermoformable within said target temperature range and generally rigid at temperatures below said target temperature range, and wherein said foam layers have a lower density than said polymer layer of said middle layer and said foam layers and said middle layer are integrally formed as a composite layer material, the method comprising:

heating said shell to an initial temperature of less than 300 degrees Fahrenheit;
applying said shell at least partially circumferentially to the body part of the patient;
and
forming said shell as said cast about the body part during a target dwell time of 3 to 10 minutes by:
thermoforming said polymer layer of said middle layer to a moldable shape during said target dwell time that generally conforms to the body part;
utilizing said foam layers of said outer layer and said inner layer to insulate said middle layer to maintain said middle layer at said target temperature range during said dwell time when said shell is heated to said initial temperature;
causing said foam layers of said outer layer and said inner layer to stretch to conform to a moldable shape of said polymer layer of said middle layer without thermoforming at said target temperature range;
and
allowing said polymer layer of said middle layer to cool after said target dwell time to assume a generally rigid version of said moldable shape.

6 more elements

A method, comprising:

providing a cast system for supporting a body part, said cast system including:
a shell formed of a composite layer material having an inner layer defining an area generally facing toward the body part, an outer layer defining an area generally facing away from the body part, said area of said outer layer being generally similar to said area of said inner layer, and a middle layer generally coextensive with said areas of said inner layer and said outer layer and completely encapsulated and sandwiched between said inner layer and said outer layer,
wherein said inner layer and said outer layer each comprise a foam layer that is stretchable within a target temperature range and said middle layer comprises a polymer layer that is thermoformable within said target temperature range and generally rigid at temperatures below said target temperature range, and wherein said foam layers have a lower density than said polymer layer of said middle layer and said foam layers and said middle layer are integrally formed as a composite layer material,
providing instructions for applying said cast system to the body part of the patient, the instructions including:
heating said shell to an initial temperature of less than 300 degrees Fahrenheit;
applying said shell at least partially circumferentially to the body part of the patient;
and
forming said shell as said cast about the body part during a target dwell time of 3 to 10 minutes by:
thermoforming said polymer layer of said middle layer to a moldable shape during said target dwell time that generally conforms to the body part;
and
allowing said polymer layer of said middle layer to cool after said target dwell time to assume a generally rigid version of said moldable shape,
such that said foam layers of said outer layer and said inner layer are utilized to insulate said middle layer to maintain said middle layer at said target temperature range during said dwell time when said shell is heated to said initial temperature and said foam layers of said outer layer and said inner layer stretch to conform to a moldable shape of said polymer layer of said middle layer.

9 more elements

Dependencies are inferred from the claim text.

Description11,144 words

Summary4,442 words

#This invention relates to the field of orthopedic systems for immobilizing and supporting human and or animal body parts and in particular, casts.

#The management of fractures and injuries to the extremities has a long and colorful history in medicine. Prior to the invention of plaster of Paris by the Flemish army surgeon Mathijsen in 1852, the stabilization of broken bones and sundry joint injuries was a haphazard affair using pieces of wood, branches, and any rigid material that might be available. Plaster of Paris was rubbed into muslin or linen cloth prior to its use, “a tedious process”, and wrapped around an injured limb to provide stability. When the anhydrous calcium sulfate was recombined with water, the reaction produced the slow drying, but stiff gypsum. Manufactured rolls of plaster of Paris cast material were not available until the mid-1900's. The casts made in this way were messy to apply, often extremely bulky, could be very difficult to remove, would break down with walking, fell apart in water, were heavy, and made visualization of a fracture difficult with x-ray. Yet at the time they were a major step forward in the medical management of these unstable musculoskeletal injuries.

#Plaster casts were used consistently and devotedly until the 1980's when fiberglass materials became available. Though more expensive and somewhat more difficult to work with, fiberglass soon became the preferred casting material in many clinics and hospitals, and remains so today. It offered increased lightness, somewhat better visibility under x-ray, and was resistant to softening if wet. Unlike plaster rolls or strips which could remain open on the shelf, fiberglass would gradually harden if exposed to air and needed to be packaged in airtight bags. Fiberglass still required water activation to harden into a usable cast, and was highly user dependent in the quality of the final product. It has sharp edges, folded corners can produce skin ulcers, and it can be more difficult to remove than plaster. It is available in rolls of various sizes (2″, 3″, 4″, 5″, & 6″) A cast saw with a good blade is necessary for its removal. Fiberglass and plaster remain the most commonly used material casting in orthopedics today.

Brief description of the drawings29 figures

#FIG. 1 is top view of a unitized casting system of a preferred embodiment of the present invention.

#FIG. 2 is a disassembled view of the layers of the embodiment of FIG. 1.

#FIG. 3 is a detail view of the disassembled view of the layers of the embodiment of FIG. 1.

Detailed description6,194 words

#A preferred embodiment of the present invention is illustrated in FIGS. 1-29. It is to be expressly understood that the descriptive embodiments are provided herein for explanatory purposes only and are not meant to unduly limit the claimed inventions. The exemplary embodiments describe the present invention in terms of cast systems used for immobilizing and supporting body part as shown in FIGS. 1-29. It is to be understood that the present invention is intended for use with other types of medical, sports, veterinary and other types of uses.

#Overview

#The system, in a preferred embodiment, provides a unitized casting system that is far superior to previous systems. The system of a preferred embodiment of the present invention, as used as a cast, is shown in FIGS. 1-6. This cast system is illustrated as a wrist cast but it is to be expressly understood that it can be used for any type of casting situation, such as but not limited to foot casts, neck casts, leg casts, arm casts etc. This cast system 10 of this embodiment includes an outer durable padding layer 20, a mid support layer 30 and an inner comfort padding layer 40 as shown in FIG. 2. The three layers each provide unique functions and when combined into a unitized cast create a unique and superior cast. The three layers, each described in greater detail below, are molded or laminated together to form a unitized cast. Closures 50 are applied prior to use that enable a health care provider without specialized training to easily form the cast in an appropriate shape and secure the cast to the patient. The resulting cast is much more comfortable for the patient and can increase the patient's compliance with its use. The resulting cast has many additional benefits over the previous systems as discussed above and below.

Facts

Application

12/013,449Filed 13 Jan 2008 · us provisional application

Priority

20 Jun 2007

Published

US 2008/0319362 A125 Dec 2008

Granted

6 Nov 2012

Term ends

17 Aug 2028

Estimated · how

20 years from earliest known nonprovisional domestic filing plus recorded patent term adjustment, including 217 days of adjustment. Maintenance-fee lapses, terminal disclaimers and statutory extensions have not been checked. The continuity chain may be incomplete; this is not an enforceability determination.

Classification8 codes

A61F 13/046
Accessories for stiffening bandages, e.g. cast liners, heel-pieces: incorporated ventilation or cooling devices
A61F 5/01
Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices: orthopaedic devices, e.g.…
A61F 5/0102
Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or…
A61F 5/0111
Without articulation: for the feet or ankles

Timeline

20 Jun 2007Priority claimedParent application 60/945,277
13 Jan 2008Application filedUS 12/013,449
13 Jan 2008Assigned to Exos Corporationassignment of assignor's interest
25 Dec 2008PublishedUS 2008/0319362 A1
22 Feb 2012Assigned to Exos Corporationconfirmation of assignment
8 Mar 2012Assigned to Product Innovations, Inc.security agreement
6 Nov 2012GrantedUS 8,303,527 B2
19 Feb 2014Assigned to Exos LLCchange of name
7 May 2015Assigned to Wells Fargo Bank, National Association, AS the Collateral Agentsecurity interest
18 May 2015Assigned to Macquarie US Trading LLC, AS Collateral Agentsecurity agreement
18 May 2015Assigned to The Bank of New York Mellon, AS Second Lien Agentsecurity agreement
18 May 2015Assigned to The Bank of New York Mellon, AS Third Lien Agentsecurity agreement
17 Apr 2017Assigned to Djo, LLCmerger
13 Dec 2018Assigned to Exos Corporationrelease of security interest
14 Mar 2019Assigned to Djo, LLC, Encore Medical, L.P., Empi, Inc., Encore Medical Asset Corporation, Rikco International, LLCrelease of security interest
14 Mar 2019Assigned to Djo, LLC, Encore Medical, L.P., Empi, Inc., Encore Medical Asset Corporation, Rikco International, LLCrelease of security interest
14 Mar 2019Assigned to Djo, LLC, Encore Medical, L.P., Empi, Inc., Encore Medical Asset Corporation, Rikco International, LLCrelease of security interest
21 Mar 2019Assigned to Djo, LLC, Encore Medical, L.P., Empi, Inc., Encore Medical Asset Corporation, Rikco International, LLCrelease of security interest
3 Jan 2024Assigned to Jpmorgan Chase Bank, N.A., AS Administrative Agentsecurity interest
12 Oct 2026TodayWithin its term
17 Aug 2028Term endsEstimated, includes 217 days of adjustment

Orthopedic system for immobilizing and supporting body parts

Life of this patent

Orthopedic system for immobilizing and supporting body parts

Life of this patent

Life of this patent

Abstract

Drawings

Drawings

Claims21

Description11,144 words

Drawings

Classification8 codes

Life of this patent

Description11,144 words